Incidence OIRD Medical and Trauma Patients

• Conditions: Respiratory Depression; Sedation

• Registration Number: NCT03948880
• Lead Sponsor: Fresno Community Hospital and Medical Center

Brief Summary

The primary objective of this prospective, blinded observational study is to correlate assessment of sedation and respiratory status with capnography and pulse oximetry monitoring in hospitalized adult medical and trauma patients receiving patient-controlled analgesia (PCA) or nurse administered intravenous opioids for acute pain. Nursing assessment of respiratory status and sedation level will be correlated with capnography and pulse oximetry values as technology-supported monitoring to identify respiratory depression and opioid-induced sedation. The secondary objective is to identify capnography and pulse oximetry values that correlate with respiratory decompensation and opioid-induced sedation in medical and trauma patients on the general care floor.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-10
• Study First Submitted QC: 2019-05-10
• Study First Posted: 2019-05-14
• Status Verified: 2019-07
• Study Start: 2019-07-29
• Last Update Submitted: 2019-07-29
• Last Update Posted: 2019-07-31
• Primary Completion: 2019-10-29
• Study Completion: 2019-11-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

1. Spontaneously breathing adults 18 to 89 years of age
2. Receiving PCA or nurse administered IV opioids for medical or trauma-related pain
3. Admitted to the general care floor from the emergency department
4. Able to provide written informed consent

Exclusion Criteria

1. Age is less than 18 years or greater than 89 years
2. Transfer to the general care floor from the ICU
3. Provider order for respiratory monitoring using continuous capnography
4. Receiving intrathecal or epidural opioids
5. Trauma patient with a nerve block
6. Inability or unwillingness to wear the EtCO2 sampling line nasal cannula or pulse oximetry sensor
7. History or diagnosis of a sleep disordered breathing syndrome
8. Use of CPAP or BIPAP non-invasive ventilation as home regime
9. Pre-existing co-morbidity that impacts respiration or ventilation (e.g. COPD or pulmonary fibrosis) (for the purpose of this study a trauma patient with rib fractures is not considered having a pre-existing condition)
10. Receiving non-invasive ventilation
11. Unable or unwilling to participate
12. Member of a vulnerable population such as pregnant women or prisoners

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hypoventilation	Change from baseline measurement observed within 60 minutes after opioid administration	The characteristics of subjects who experience hypoventilation using respiratory monitoring with continuous capnography for data collection.

Secondary Outcome Measures

Name	Time	Method
Hypoxemia	Change from baseline measurement observed within 60 minutes after opioid administration ]	The characteristics of subjects who experience oxygen desaturation using respiratory monitoring with continuous pulse oximetry for data collection.

Trial Locations

Locations (1)

Community Regional Medical Center; 🇺🇸 Fresno, California, United States